Part D Drug Management Program (CMS-10874)

Forms and Documents

Document Name	Status
Form CMS-10874 Part D Drug Management Program Form	Modified
CMS-10874 - Justification for a Nonsubstantive Change-12.23.24.docx Justification for No Material/Nonsubstantive Change	2024-12-26
CMS-10874 - Supporting Statement A (CMS-4205-F version 8).docx Supporting Statement A	2024-08-08

IC Document Collections

IC ID	Document Title	Status
264405	Part D Drug Management Program Form	Modified

ICR Details

OMB Control No: 0938-1465	ICR Reference No: 202412-0938-018
Status: Received in OIRA	Previous ICR Reference No: 202408-0938-008
Agency/Subagency: HHS/CMS	Agency Tracking No: CM-CPC
Title: Part D Drug Management Program (CMS-10874)
Type of Information Collection: No material or nonsubstantive change to a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular	Date Submitted to OIRA: 12/26/2024

	Requested	Previously Approved
Expiration Date	11/30/2027	11/30/2027
Responses	62,248	62,248
Time Burden (Hours)	152,585	152,585
Cost Burden (Dollars)	0	0

---

Abstract: Pursuant to Section 1860D-4(c)(5)(A) of the SSA, Part D sponsors will use the standardized and model documents to communicate with providers, enrollees, and other sponsors. Specifically, Part D sponsors may use the Model Part D Drug Management Program Prescriber Inquiry Letter to inform providers that their patient’s pattern of use or history of use of FADs is potentially unsafe and has prompted a case management review under the plan’s DMP. Part D sponsors must use the standardized Initial Notice and Second Notice, or Alternate Second Notice, to inform enrollees, following identification by CMS’s OMS and subsequent case management, whether the beneficiaries have been identified as being potentially at risk or at risk for abuse or misuse of FADs. Part D sponsors may use the Model Part D Drug Management Program Sponsor Information Transfer Memorandum to communicate to a gaining sponsor the enrollee’s history of misuse or abuse of FADs.

---

Authorizing Statute(s): US Code: 42 USC 1860D-4(c)(5)(A) Name of Law: Social Security Act
  

Citations for New Statutory Requirements: None

---

Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
0938-AV24	Final or interim final rulemaking	89 FR 30448	04/23/2024

---

Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	88 FR 78476	11/15/2023
30-day Notice:	Federal Register Citation:	Citation Date:
	89 FR 30448	04/23/2024
Did the Agency receive public comments on this ICR? Yes

---

Number of Information Collection (IC) in this ICR: 1

IC Title	Form No.	Form Name
Part D Drug Management Program	CMS-10874, CMS-10874, CMS-10874, CMS-10874, CMS-10874	Initial Notice ,   Second Notice ,   Alternate Second Notice ,   Model Prescriber Inquiry Letter ,   Model Sponsor Information Transfer Memorandum

---

ICR Summary of Burden

	Total Request	Previously Approved	Change Due to New Statute	Change Due to Agency Discretion	Change Due to Adjustment in Estimate	Change Due to Potential Violation of the PRA
Annual Number of Responses	62,248	62,248	0	0	0	0
Annual Time Burden (Hours)	152,585	152,585	0	0	0	0
Annual Cost Burden (Dollars)	0	0	0	0	0	0

Burden increases because of Program Change due to Agency Discretion: No

Burden Increase Due to:

Burden decreases because of Program Change due to Agency Discretion: No

Burden Reduction Due to:

Short Statement: This is a new information collection request, in which we include information collection instruments and related requirements/burden from CMS-10141 (OMB control number 0938-0964) along with changes associated with our April 23, 2024 (89 FR 30448) final rule (CMS-4205-F, RIN 0938-AV24). Overall, the collection consists of: 319 respondents, 62,248 responses, and 152,585 hours.

---

Annual Cost to Federal Government: $47,025

Does this IC contain surveys, censuses, or employ statistical methods? No

Does this ICR request any personally identifiable information (see OMB Circular No. A-130 for an explanation of this term)? Please consult with your agency's privacy program when making this determination.     No

Does this ICR include a form that requires a Privacy Act Statement (see 5 U.S.C. §552a(e)(3))? Please consult with your agency's privacy program when making this determination.     No

Is this ICR related to the Affordable Care Act [Pub. L. 111-148 & 111-152]? No

Is this ICR related to the Dodd-Frank Wall Street Reform and Consumer Protection Act, [Pub. L. 111-203]? No

Is this ICR related to the American Recovery and Reinvestment Act of 2009 (ARRA)? No

Is this ICR related to the Pandemic Response? No

---

Common Form ICR:  No

---

On behalf of this Federal agency, I certify that the collection of information encompassed by this request complies with 5 CFR 1320.9 and the related provisions of 5 CFR 1320.8(b)(3).

The following is a summary of the topics, regarding the proposed collection of information, that the certification covers:

(a) It is necessary for the proper performance of agency functions;

(b) It avoids unnecessary duplication;

(c) It reduces burden on small entities;

(d) It uses plain, coherent, and unambiguous language that is understandable to respondents;

(e) Its implementation will be consistent and compatible with current reporting and recordkeeping practices;

(f) It indicates the retention periods for recordkeeping requirements;

(g) It informs respondents of the information called for under 5 CFR 1320.8 (b)(3) about:

(i) Why the information is being collected;

(ii) Use of information;

(iii) Burden estimate;

(iv) Nature of response (voluntary, required for a benefit, or mandatory);

(v) Nature and extent of confidentiality; and

(vi) Need to display currently valid OMB control number;

(h) It was developed by an office that has planned and allocated resources for the efficient and effective management and use of the information to be collected.

(i) It uses effective and efficient statistical survey methodology (if applicable); and

(j) It makes appropriate use of information technology.

If you are unable to certify compliance with any of these provisions, identify the item by leaving the box unchecked and explain the reason in the Supporting Statement.

Certification Date: 12/26/2024

---